GlaxoSmithKline has filed with the European Medicines Agency its Innoviva-partnered, once-daily, closed triple combination therapy as a treatment for patients with chronic obstructive pulmonary disease (COPD).
The therapy is comprised of three medicines: fluticasone furoate (FF), an inhaled corticosteroid (ICS), umeclidinium (UME), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA), delivered via GSK's Ellipta dry powder inhaler.
The company is seeking permission to market the combo for maintenance treatment to relieve symptoms of adult patients with COPD, the second most common lung disease in the UK after asthma affecting 4.5 percent of all people aged over 40, according to the British Lung Foundation.
Earlier this year, the firms unveiled data from the FULFIL study showing statistically significant improvements with the triple therapy compared with the dual therapy Symbicort Turbohaler (budesonide/formoterol) in both lung function, as measured by trough FEV1 (+171 mL), and health-related quality of life, as measured by the St. George's Respiratory Questionnaire (-6.6 versus -4.3, respectively).
Also, the study showed a statistically significant and clinically meaningful reduction in the annual rate of moderate/severe exacerbations with FF/UMEC/VI compared to Symbicort Turbohaler, with closed triple therapy showing a 35 percent reduction based on data up to 24 weeks and a 44 percent reduction in the subset of patients that received treatment for up to 52 weeks.
"If approved, FF/UMEC/VI as once-daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients," noted Mike Aguiar, Innoviva's chief executive.
The closed triple therapy was filed in the US last month, submissions in the rest of the world are expected from next year.